Now’s our time to inspire the future of healthcare together.
Siemens Healthineers is a leading global medical technology company with over 170 years of experience and 18,000 patents. More than 60,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. We stand with our customers around the world to support them in delivering high quality care to their patients. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services. This is what truly matters to us.
Join our team now at Siemens Healthineers as the Quality Specialist / Recall Coordinator in the Ultrasound Business Area
This is a role well suited to an ambitious
professional, looking for the next step in their career. As a Recall Coordinator, you will be responsible for:
- Execute the daily activities of Recall Management for the Post Marker Surveillance team.
- Process assigned recalls in accordance with the Recall Policy and established procedures and responds with the appropriate level of urgency.
- Work with a cross-functional team of Product Management, Engineering and Quality subject matter experts to define and meet the deliverable of each recall as needed
- Communicate with external regulatory agencies and internal stakeholders to provide updates and resolve outstanding questions concerning current field corrections
- Adjusts priority of work assignments to ensure prompt and efficient completion of all activities for the Recall Coordination; consults with Quality and Regulatory leadership for guidance as needed.
This position may suit you best if you are familiar
with what is below, and would like to do develop your career with
- FDA 21 CFR 820, 803, 806 and ISO13485, EU MDR / MDD, and other global requirements related to Recalls and Vigilance activities.
- Strong project management skills.
- Effective writing and communication skills.
- Proactively reviewing the quality system and participating in special projects with a focus on continuous improvement in relevant job functions.
- Assisting with the coordination of external audits from regulatory authorities
- Staying current with applicable regulations, quality standards/systems for all company products and markets
Required skills to have for the success of this role
- Bachelor’s degree or equivalent experience required
- Minimum of 5-8 years Medical Device industry experience in a Quality function, including direct experience in recall coordination and management.
- Experience in other Quality System elements a plus.
- Good working knowledge of FDA and international medical device regulations
Siemens Healthineers has recently announced the next steps in our continued commitment to prioritize colleague health, comply with customer/business partner requirements, and help preserve our business continuity. Going forward, please be aware that Siemens Healthineers requires full COVID-19 vaccination for all new hires by their start date except where prohibited by state law.
(Note: Accommodations may be requested for certain medical or religious reasons)
At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose: To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.
If you want to join us in transforming the way healthcare is delivered, visit our career site at https://usa.healthcare.siemens.com/careers.
If you wish to find out more about the specific before applying, please visit: https://usa.healthcare.siemens.com/about.
As an equal-opportunity employer we are happy to consider applications from individuals with disabilities.
Organization: Siemens Healthineers
Company: Siemens Medical Solutions USA, Inc.
Experience Level: Experienced Professional
Job Type: Full-time
Equal Employment Opportunity Statement
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